Stomach acid pill may change how new myelofibrosis drug works
NCT ID NCT07608666
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 4 times
Summary
This early-stage study in 16 healthy adults checks if taking a common stomach acid drug (rabeprazole) changes how the body absorbs a new experimental drug (TQ05105) being developed for myelofibrosis. Participants take TQ05105 alone and later with rabeprazole to compare drug levels. The goal is to understand potential interactions, not to treat disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Jul 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent prior to the study, fully understood the study content, procedures and potential adverse reactions; able to complete the study per protocol requirements. * The participant (including partner) agrees not to plan pregnancy, sperm donation or egg donation from screening until 6 months after the last study drug administration, and is willing to use effective contraception. * Healthy male and female participants aged 18-45 years (inclusive). * Male body weight ≥ 50.0 kg; female body weight ≥ 45.0 kg.BMI = weight (kg)/height² (m²), range 18.0-28.0 kg/m² (inclusive). Exclusion Criteria: * Participants with clinically significant abnormalities in vital signs, physical examination, ECG or clinical laboratory tests, and deemed unsuitable for participation by the investigator. * Participants with severe or chronic diseases of the circulatory, digestive, respiratory, urinary, nervous, hematologic, endocrine/metabolic, neoplastic, immune or psychiatric systems within the past 1 year or currently, or any other disease that may interfere with study results. * Platelet count or absolute neutrophil count below the lower limit of the reference range at screening. * Any disease increasing bleeding risk, such as hemorrhoids, acute gastritis, gastric or duodenal ulcer. * Alanine aminotransferase (ALT) \> 1.2×ULN, aspartate aminotransferase (AST) \> 1.2×ULN, alkaline phosphatase (ALP) \> 1.2×ULN, total bilirubin (TBIL) \> 1.2×ULN, or any clinically significant abnormality judged by the investigator. * Any malignancy within the past 5 years. * Any condition that may affect absorption, distribution, metabolism or excretion of study drug (e.g., inability to swallow), or history of gastrointestinal resection that may affect drug disposition. * Allergy to rabeprazole, TQ05105 or their excipients; or history of multiple allergies (≥2 substances), including drug allergy, and tendency to develop rash, eczema, urticaria, asthma, etc. * Use of any strong or moderate inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C19 within 4 weeks prior to screening. * Use of any prescription drugs, over the counter medications, herbal medicines or dietary supplements (e.g., vitamins, calcium supplements) within 4 weeks prior to screening. * Use of any acid suppressive therapy within 3 months prior to screening. * Participation in any clinical trial involving investigational drugs within 3 months prior to screening or within 5 half lives of the study drug (whichever is longer). * Positive results for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or syphilis antibody. * Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73m² at screening. * Average daily cigarette consumption \>5 cigarettes within 3 months prior to screening. * History of drug abuse within 3 months prior to screening, or positive urine drug screen. * Regular alcohol consumption within 3 months prior to screening (≥14 units/week; 1 unit = 360 mL beer / 45 mL 40% spirits / 150 mL wine), or positive alcohol breath test. * Blood donation or blood loss ≥200 mL, or plasma exchange within 4 weeks prior to screening. * Consumption of alcohol (or positive alcohol breath test), grapefruit juice, coffee, tea, cola, chocolate or related food/beverage within 72 hours before dosing. * Pregnant or breastfeeding female participants, positive serum pregnancy test, or unprotected sexual intercourse within 2 weeks prior to screening for women of childbearing potential. * Strenuous exercise (e.g., marathon, weightlifting) within 2 weeks prior to screening. * Any other condition deemed unsuitable for participation by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Third Xiangya Hospital, Central South University
Changsha, Hunan, 410013, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as cure for myelofibrosis
- Can blood tests predict transplant complications?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?
- Can a new pill tame myelofibrosis?
- MRI as a window into bone marrow disease: a new biomarker test?
- Can a menin inhibitor tame myelofibrosis when standard drugs fall short?